If you have ever needed specially prepared medications, you may need to use the services of a compound pharmacy. According to the United States Pharmacopoeia Convention, compounding is the preparation, mixing, assembly, alteration, packaging, and labeling of a drug or device according to a supplier’s prescription or orders .
Examples of composition include preparing a special dosage of a drug; prepare a flavored version of a drug, whether it’s mixing it into a syrup for a child or a chewable treat for a pet; reformulate the drug to eliminate any non-essential allergens, such as lactose; or changing the form of a drug, such as mixing it into a liquid form for patients who cannot swallow pills.
There are compound pharmacies because sometimes the commercially available drugs don’t work for the needs of the patients. This is when a compounding pharmacy (and pharmacist) can step in. While most pharmacies (and pharmacists) may do a limited amount of compounding, more specialized orders often go to specialty compounding locations, where pharmacists have specialized tools, training, and ingredients available.
How to use a compound pharmacy
A compound medicine is specially prepared for an individual patient and requires a prescription. Of the approx 56,000 pharmacies in the United StatesApproximately 7,500 of them are dedicated compounding pharmacies. To find a compounding pharmacy near you, you can search for Alliance For Pharmacy Compoundings website locator. If your doctor wants to prescribe a drug that must be filled from a compound pharmacy, they will also likely have a local recommendation.
As the Alliance For Pharmacy Compounding suggests, when choosing a compounding pharmacy, it is wise to ask about quality standards, including whether they adhere to the United States Pharmacopoeia standard; training of pharmacy personnel; the composition process by which the drug will be prepared, including sterile procedures for any eye drops or injections; and if they are accredited by Pharmaceutical Compounding Accreditation Council.
What to be aware of
There have been a number of warnings and controversies in the past due to unsafe drugs prepared by compounding pharmacies, including a Fungal meningitis outbreak of 2012, where 753 patients in 20 states developed a fungal infection after being injected with a contaminated drug that was prepped by a compound pharmacy. Since then, the FDA has released it periodically reports of contaminated products which were prepared in compounding pharmacies.
More recently, the FDA issued a warning about custom preparations semaglutidewhich is the active ingredient present in Ozempico AND Wegovywhich are sold by compounding pharmacies at lower cost, due to a The FDA loophole saying that patented drugs can be aggravated during shortages.
However, as the FDA recently warned, there are a number of risks associated with the use of these compound preparations, as there have been adverse events reported in patients using them. The company that makes semaglutide doesn’t sell it in a form that can be used by compound pharmacies; instead, these pharmacies may use research-grade semaglutide salts. The FDA says yes I am not aware of any way this could be done legallywhich means Ozempic compound probably isn’t the real deal.
Like the FDA Notes, one of the main differences between a commercially available drug and a compound drug is that the quality standards are different. A commercially available drug must go through the FDA approval process and is subject to a number of quality control regulations, while a compound drug is not considered FDA approved. A compound drug can be made from an FDA approved drug, but the compounding process has a different set of rules and regulations, which are not subject to the FDA approval process.